Ophthalmology - Luxturna

Covered: One-time Luxturna treatment (one 1.5×10^11 vg subretinal injection per eye, second eye ≥6 days after the first) is authorized for genetically‑confirmed biallelic RPE65 mutation‑associated retinal dystrophy in patients aged ≥12 months and <65 years, while re‑treatment of previously treated eyes and non‑FDA indications are excluded. Key requirements: documentation of biallelic RPE65 genetic test, patient age, treating‑physician confirmation of viable retinal cells, confirmation the eye(s) have not received Luxturna previously, and a procedure plan showing dose, route, and scheduling.

"Biallelic human retinal pigment epithelial 65 kDa protein (RPE65) mutation-associated retinal dystrophy (FDA‑approved indication). Approve for one-time treatment course (i."

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